Conference · London, United Kingdom
Understanding and Preparing the Quality and Pharmaceutical Module of the Global CTD Dossier
Pharmaceuticals
Key numbers
- Editions on record
- 1first in 2014
About Understanding and Preparing the Quality and Pharmaceutical Module of the Global CTD Dossier
This 3-day course will provide you with a clear understanding of the US and European regulatory requirements for Module 3 (CTD) of your application, and will show you how to compile this important part of your submission dossier. The course sessions will also examine the impact of the Common Technical Document. This course will teach you how to:
. Build Module 3 (CTD) of the dossier
. Know the legal framework and guidelines
. Meet the legal responsibilities of the manufacturing authorisation holder
. Write the application
. Define the impact of the Common Technical Document
. Write variation submissions for Europe
. Structure your submission teams
. Link your dossier requirements to GMP
. Minimise delays in your submission
. Use certificate of suitability as replacement of data
Price:
Book before the 25th April 2014: £1,795.00 + (VAT @ 20.00%) = £2,154.00
Book after the 25th April 2014: £1,895.00 + (VAT @ 20.00%) = £2,274.00
From our listing of this edition. Details may have changed since.
Editions
| Year | Dates | Where | Exhibitors | Visitors |
|---|---|---|---|---|
| 2014 | 21–23 May 2014 | Radisson Blu Edwardian Grafton London, United Kingdom | — | — |
Past editions from the bvents archive (2008–2019) and organiser figures where they were published.
Questions
When is Understanding and Preparing the Quality and Pharmaceutical Module of the Global CTD Dossier?
The next dates haven't been confirmed. The last edition we have on record was 21–23 May 2014.
Where is it held?
The last edition we have was at Radisson Blu Edwardian Grafton, London, United Kingdom.